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Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.

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ClinicalTrials.gov Identifier: NCT03234452
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Montefarmaco OTC SpA

Tracking Information
First Submitted Date  ICMJE July 26, 2017
First Posted Date  ICMJE July 31, 2017
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE March 23, 2016
Actual Primary Completion Date July 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
NK activity [ Time Frame: 45 days ]
Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • IgA, IL8, TNF-Alpha, IL10 [ Time Frame: 45 days ]
  • Cortisol, alpha-amylase , chromogranin A [ Time Frame: 45 days ]
  • microbiota composition investigation [ Time Frame: 45 days ]
  • Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation ) [ Time Frame: 45 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
Official Title  ICMJE Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.
Brief Summary A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE
  • Disbiosis
  • Abdominal Pain
  • Constipation
  • Diarrhea
  • Stress
Intervention  ICMJE
  • Dietary Supplement: Lactoflorene plus
    2 vials with dosing cap (10 mL) a day per os
  • Dietary Supplement: Placebo Lactoflorene plus
    2 vials with dosing cap (10 mL) a day per os
Study Arms  ICMJE
  • Experimental: Lactoflorene plus
    10 ml mixture of Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431® , Bacillus coagulans BC513, zinc and B-vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) twice a day
    Intervention: Dietary Supplement: Lactoflorene plus
  • Placebo Comparator: Placebo Lactoflorene plus
    Identical placebo mixture without probiotics, B-vitamins and zinc. The active and placebo products had similar appearance, taste and smell and were provided in identical bottles of 10 ml with identical labelling.
    Intervention: Dietary Supplement: Placebo Lactoflorene plus
Publications * Soldi S, Tagliacarne SC, Valsecchi C, Perna S, Rondanelli M, Ziviani L, Milleri S, Annoni A, Castellazzi A. Effect of a multistrain probiotic (Lactoflorene(®) Plus) on inflammatory parameters and microbiota composition in subjects with stress-related symptoms. Neurobiol Stress. 2018 Nov 7;10:100138. doi: 10.1016/j.ynstr.2018.11.001. eCollection 2019 Feb.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2017)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 18, 2017
Actual Primary Completion Date July 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.

Exclusion Criteria:

Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03234452
Other Study ID Numbers  ICMJE Lactoflorene plus
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Montefarmaco OTC SpA
Study Sponsor  ICMJE Montefarmaco OTC SpA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Montefarmaco OTC SpA
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP